The Recall Desk
SevereFDA (Drugs)·D-1396-2016·Announced 2016-07-27

FDA Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates

Pharmedium Services is recalling 97,716 bags of sterile injectable fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves the presence of glass particulate matter in sterile injectable drugs, which poses a significant risk of injury to patients.

Plain-English summary

Pharmedium Services, LLC is recalling 97,716 bags of 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter.

The affected products are distributed nationwide and are available in various bag sizes, including 100 ml, 125 ml, 150 ml, 200 ml, and 250 ml volumes, packaged in Hospira LifeCare Bags and Baxter Intravia Bags. The recall covers numerous specific lot numbers and expiration dates ranging from May 2016 to July 2016.

Healthcare facilities and patients who have received or are using these specific lots of injectable medication should stop using them and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
97,716

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Service Code 3V8705
  • Lot Number 160380161M
  • Exp. Date 5/8/2016
  • Lot Number 160400200M
  • Exp. Date 5/10/2016
  • Lot Number 160460205M
  • Exp. Date 5/15/2016
  • Lot Number 160530278M
  • Exp. Date 5/23/2016
  • Lot Number 160610204M
  • Exp. Date 5/31/2016
  • Lot Number 160630155M
  • Exp. Date 6/2/2016
  • Lot Number 160700159M
  • Exp. Date 6/9/2016
  • Lot Number 160770234M
  • Exp. Date 6/16/2016
  • Lot Number 160800199M
  • Exp. Date 6/19/2016
  • Lot Number 160840217M

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 75 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 75 products in this recall →

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